abmc_8k
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A-1
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of
1934
Date of
Report (Date of earliest event reported): May 29, 2020
AMERICAN BIO MEDICA
CORPORATION
(Exact
name of registrant as specified in its charter)
New
York
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0-28666
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14-1702188
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(State or other
jurisdiction of incorporation)
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(Commission File
Number)
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(IRS Employer
Identification Number)
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122
Smith Road, Kinderhook, NY
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12106
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(Address of
principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: 518-758-8158
Not applicable
(Former name or former address, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see
General Instruction A.2.
below):
☐ Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
☐ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title of each
class
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Trading
Symbol(s)
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Name of each
exchange on which registered
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Common
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ABMC
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Over-the-counter-Pink
Sheets
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this
chapter).
Emerging
growth company ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
ITEM 7.01
REGULATION FD DISCLOSURE
On
March 20, 2020, American Bio Medica Corporation (the
“Company”) announced in a press release and Form 8-K
that it was offering a COVID-19 Antibody Rapid Detection Kit to
detect COVID-19 in whole blood, serum or plasma via finger stick.
On May 29, 2020, the COVID-19 test being distributed by the Company
was authorized by the United States Food and Drug Administration
(FDA) under an Emergency Use Authorization (EUA) for use by
authorized laboratories. The product, manufactured by Healgen
Scientific, LLC, has been authorized only for the presence of IgM
and IgG antibodies against SARS-CoV-2, not for any other viruses or
pathogens. The product is intended for professional use and not for
home use. The Company will continue to market the COVID-19 test in
full compliance with FDA policy and the EUA.
The
information in this Item 7.01 is furnished pursuant to Item 7.01
and shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934 or otherwise
subject to the liabilities of that section.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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AMERICAN BIO MEDICA
CORPORATION (Registrant) |
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Date:
June 2,
2020
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By:
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/s/ Melissa A.
Waterhouse
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Melissa A.
Waterhouse
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Chief
Executive Officer (Principal Executive Officer)
Principal Financial
Officer
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